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Completed

NCT Number: NCT03137641

Nurses Internal Contamination by Antineoplastic Drugs.

CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pellegrin, Bordeaux, France

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About this study

The increase of cancer incidence contributes to a growing number of administered chemotherapies in care services. These antineoplastic drugs are not selective in their mechanisms of action, affecting noncancerous as well as cancerous cells, leading to several known side effects in treated patients. Health care professionals are increasingly exposed to antineoplastic drugs and can be potentially contaminated by these molecules. This is a key concern as part of assessment and occupational risk management in healthcare settings.

Occupational Health and Safety Department, in collaboration with Clinical and Toxicology Laboratory of university Hospital Bordeaux, developed analytical tools to assess this contamination in health care professional's urines, and the new acquisition of a high-sensitivity measurement equipment (LC-MS/MS) improved assays methods in terms of sensitivity and detection limits.

The main objective of the study is to assess internal contamination prevalence by the studied antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in nursing staff who administers these chemotherapies or is in charge of patients treated by these chemotherapies, in two French hospital centers: University Hospital Bordeaux and IUCT-Oncopole of Toulouse (Institut Universitaire du Cancer de Toulouse), including about fifteen services selected on their use of these specific chemotherapies.

The secondary objectives of the study are on the one hand, to describe for each of the five studied antineoplastic drugs the internal contamination prevalence in nursing staff, and concentration level associated to this contamination in contaminated nursing staff, and on the other hand, to identify contamination-associated factors in exposure characteristics and personal protective equipment use.

This is a descriptive, multicentre, transverse and prospective study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be a nurse with Registered Nurse Licensure (IDE: Infirmier Diplômé d'Etat), practising in one of the selected services in Bordeaux teaching hospital or in IUCT-Oncopole,
  • To have used at least one of the five antineoplastic drugs and/or to have cared one patient treated by one of the five antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in the workday of participation to the study (day with urine samples),
  • To have accepted to participate to the study and signed the participation consent form.

Exclusion criteria

  • To be a nursing student,
  • To be treated or to have been treated in the year before the workday of study participation by one of the five antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate)
  • To have at home, someone treated by one of the five antineoplastic drugs in the month before the workday of study participation

Treatment and study plan

Nurses urine samples

Other

Collected urine samples from nurses in contact with antineoplastic drugs.

Primary outcomes

  1. Internal contamination by at least one antineoplastic drug.

    Time frame: inclusion day

    Presence or absence of internal contamination by at least one antineoplastic drug of the five studied antineoplastic drugs (5-fluorouracil, cyclophosphamide, doxorubicin, ifosfamide, methotrexate) in at least one of the three urine samples collected by subject.

Secondary outcomes

  1. Nurses contamination prevalence.

    Time frame: inclusion day

    5 studied antineoplastic drugs concentration in urine samples.

  2. Socio-demographic factors.

    Time frame: inclusion day

    Assessed by age, sexe, pregnancy, cigarette addiction questionnaire

  3. Practical work conditions.

    Time frame: inclusion day

    Assessed by practical work conditions questionnaires.

  4. Patients management treated by 5 studied antineoplastic drugs.

    Time frame: inclusion day

    Assessed by practical work conditions questionnaires.

  5. Safety equipment use.

    Time frame: inclusion day

    Assessed by safety equipment questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Bordeaux PharmacoEpi

Registry information

Official study title

Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.

Acronym: CACIES

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 3, 2017
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.